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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
Classification Namestent, coronary
Generic Namestent, coronary
one scimed place
maple grove, MN 55311
PMA NumberP970061
Date Received12/22/1997
Decision Date07/16/1998
Withdrawal Date 07/17/2007
Product Code
MAF[ Registered Establishments with MAF ]
Docket Number 99M-1980
Notice Date 06/28/1999
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
The device is indicated for use in patients with symptomatic ischemic heart disease due to discrete de novo native coronary artery lesions (length <30 mm) with a reference vessel diameter ranging from 2.75 mm to 4.25 mm and is intended to improve coronary luminal diameter. Long-term outcome (beyond 6 months) for this permanent implatn is unknown.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 S013 S014 S015 S016 S017 S018 
S020 S021